Recent Updates
Recently added Catalysts

GW766944

Phase 2

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Apr 13, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01160224Oral GW766944 (Oral CCR3 Antagonist)PHASE2 COMPLETED 60Sep 8, 2010Aug 29, 2011Apr 13, 20175 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of eosinophils (absolute cell count) in induced sputum
Day 10

Sputum was collected according to the Hargreave/Nair Sputum Induction procedures.Each site performed their sputum analysis locally. Sputum induction for eosinophils was carried out at screening and Day 10. The absolute cell count of eosinophils in induced sputum has been presented.

Number of eosinophils (absolute cell count) in induced sputum following predisone
Day 22

Sputum was collected according to the Hargreave/Nair Sputum Induction procedures. Each site performed their sputum analysis locally. At Visit 5 (Day 17), all participants were given 30 mg oral daily prednisone for 5 days and participants returned to clinic at a Post Oral Prednisone Visit (Visit 6) at Day 22. Sputum induction for eosinophils was carried out at screening and Post Oral Prednisone Visit (Day 22). The absolute cell count of eosinophils in induced sputum has been presented.

Number of eosinophils (percentage count) in induced sputum
Day 10

Sputum was collected according to the Hargreave/Nair Sputum Induction procedures. Each site performed their sputum analysis locally. Sputum induction for eosinophils was carried out at screening and Day 10. Percentage count of eosinophils in induced sputum has been presented.

Number of eosinophils (percentage count) in induced sputum following prednisone
Day 22

Sputum was collected according to the Hargreave/Nair Sputum Induction procedures. Each site performed their sputum analysis locally. At Visit 5, all participants were given 30 mg oral daily prednisone for 5 days and participants returned to clinic at a Post Oral Prednisone Visit (Visit 6) at Day 22. Sputum induction for eosinophils was carried out at screening and Post Oral Prednisone Visit (Day 22). Percentage count of eosinophils in induced sputum has been presented.

Secondary Endpoints
Number of eosinophils (absolute cell count) in blood
Day 10
Number of eosinophils (absolute cell count) in blood following prednisone
Day 22
Eosinophil progenitors in sputum and blood
Day 1, Day 10
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
GW766944ACTIVE_COMPARATORThis is the active drug (GW766944)
PlaceboPLACEBO_COMPARATORPlacebo Arm.
Interventions
NameTypeDescription
GW766944DRUGDrug: GW766944 (Active Drug Treatment)
PlaceboOTHERThis is placebo to match.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Physician diagnosis of asthma (\>12% improvement in FEV1 with a bronchodilator or PC20 methacholine less than 8 mg/ml) documented within the past 2 years. * Males and females aged ≥18-75 years inclusive. * A female subject is eligible to participate if she is of: * Non-childbe...

Countries:Canada
Unlock Eligibility Criteria